NCT00192673

Brief Summary

The purpose of this study is

  1. 1.to determine the correct dose for intramuscular administration
  2. 2.to compare the frequency of antibody formation after intramuscular administration of native E.coli asparaginase and PEG-asparaginase during two treatment courses in the treatment of childhood lymphoblastic leukemia

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
8.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 30, 2009

Status Verified

September 1, 2009

First QC Date

September 11, 2005

Last Update Submit

September 29, 2009

Conditions

Acute Lymphoblastic Leukemia

Keywords

Asparaginaseintramuscular administrationSilent antibodiesChildhood acute lymphoblastic leukemiaSide effects5-year EFS

Outcome Measures

Primary Outcomes (2)

  • Determination of the dose that secures sufficient treatment during 14 days

  • Determination of the frequency of antibody formation during treatment with PEG-asparaginase during two treatment courses

Secondary Outcomes (1)

  • Comparison of 5-year EFS between groups

Interventions

PEG-asparaginaseDRUG

Eligibility Criteria

Age1 Year - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years
  • Newly diagnosed ALL (high intensive)
  • Treated according to the NOPHO-2000 protocol
  • Treated at one of the Nordic pediatric oncology centers

You may not qualify if:

  • \<1 year and \>18 years
  • Newly diagnosed ALL other than high intensive
  • Not treated according to the NOPHO-2000 protocol
  • Not treated at one of the Nordic pediatric oncology centers
  • Allergy to the contents
  • Pancreatitis (Active or earlier)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, Skejby Hospital

Aarhus, Aarhus N, 8200, Denmark

RECRUITING

Related Publications (1)

  • Albenberg L, Brensinger CM, Wu Q, Gilroy E, Kappelman MD, Sandler RS, Lewis JD. A Diet Low in Red and Processed Meat Does Not Reduce Rate of Crohn's Disease Flares. Gastroenterology. 2019 Jul;157(1):128-136.e5. doi: 10.1053/j.gastro.2019.03.015. Epub 2019 Mar 11.

    PMID: 30872105DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

pegaspargase

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Henrik Schrøder, M.D. PhD

    Department of Pediatrics, Skejby Hospital, Denmark and member of the Scientific Commmittee in NOPHO

    STUDY DIRECTOR

Central Study Contacts

Birgitte K Albertsen, M.D., PhD

CONTACT

+45 89495566bka@farm.au.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 19, 2005

Study Start

June 1, 2005

Study Completion

December 1, 2013

Last Updated

September 30, 2009

Record last verified: 2009-09

Locations

DK(1)